Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)

Not Applicable

Recruiting

• Conditions: Acute Coronary Syndrome; Acute Myocardial Infarction; Heart Failure; Stable Angina Pectoris; Percutaneous Coronary Intervention
• Interventions: Other: Center-Based Cardiac Rehab; Other: mHealth; Other: Home-Based Cardiac Rehab

• Registration Number: NCT04938661
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this research is to find out if doing cardiac rehab at home, or a mix of cardiac rehab at home and in the clinic, is as effective as coming in to the clinic for cardiac rehab.

Detailed Description

To address our specific aims we will use a single-center, prospective, three-arm, parallel group, randomized controlled trial design. At the time of identification of eligibility for participation, patients will be randomized to one of three arms (1:1:1 ratio): Arm 1 consists of patients randomized to conventional cardiac rehab only, Arm 2 consists of patients randomized to conventional cardiac rehab with the addition of the mHealth platform, and Arm 3 consists of patients randomized to remote case management using the mHealth platform only. Clinical metrics will include traditional cardiovascular risk factors with additional tracking of service utilization and adherence, and quality of life. Measures will be made at baseline (pre-intervention) and \~3-months (coinciding with completion of conventional CR). Additional follow-up will occur at 12 months post CR entry. Randomization to study arms will be done with a multidimensional dynamic allocation algorithm, minimizing imbalances in age, sex, body mass index, and race across study arms.

Study Timeline

• Study First Submitted: 2021-05-14
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-24
• Study Start: 2021-07-08
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 333

Inclusion Criteria

• Own or have reliable access to a smartphone or desktop computer with internet access
• Have an email address
• Patients who have a history of one of the following; acute myocardial infarction/acute coronary syndrome, stable angina pectoris, percutaneous coronary intervention, or heart failure.
• Patients who have undergone a surgical procedure which includes an indication for cardiac rehabilitation (coronary artery bypass surgery, heart valve repair/replacement, or heart transplant)

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Exclusion Criteria

• Patients referred to cardiac rehab with ventricular assist devices.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Center-Based Cardiac Rehab (CON)	Center-Based Cardiac Rehab	Participants will be prescribed 36 sessions of center-based CR. This includes supervised exercise sessions, cooking demonstrations, didactic lectures, video presentations, group support, and stress management education. During sessions, participants have direct access to the medical director, case manager, registered nurse, exercise physiologist, and stress management specialists.
Conventional Center-Based Cardiac Rehab + mHealth (CON+)	mHealth	Participants will be prescribed 36 sessions of center-based CR as noted above. In addition, participants will be provided access to the mHealth platform which provides "e-Learning modules" with factsheets, videos, quizzes, and questionnaires (coinciding with activities being conducted during the CON program), a Social Network Module will allow patients to communicate via secure network with other patients who are part of their invited network. The Social Network Module also allows for secure two-way interaction with healthcare providers in the event that patients are experiencing signs or symptoms suggestive of worsening condition. This platform also contains a Personal Health Record Module allowing patients to upload, archive, and retrieve personal health data (e.g. fitness tracker data, heart rate monitor data, blood pressure recordings, etc.) and record vital signs, symptoms, treatments, and medical history.
Home-Based Cardiac Rehab + mHealth (HOM+)	Home-Based Cardiac Rehab	Participants will be provided paper copies of educational content at the time of event/discharge. In addition, these participants will be provided access to the same mHealth platform as the CON+ group. Participants in this group will be encouraged to exercise three days per week while also completing the additional questionnaires and educational content provided by the mHealth platform in accordance with the CR program. Participation will be tracked using web/internet analytics.
Conventional Center-Based Cardiac Rehab + mHealth (CON+)	Center-Based Cardiac Rehab	Participants will be prescribed 36 sessions of center-based CR as noted above. In addition, participants will be provided access to the mHealth platform which provides "e-Learning modules" with factsheets, videos, quizzes, and questionnaires (coinciding with activities being conducted during the CON program), a Social Network Module will allow patients to communicate via secure network with other patients who are part of their invited network. The Social Network Module also allows for secure two-way interaction with healthcare providers in the event that patients are experiencing signs or symptoms suggestive of worsening condition. This platform also contains a Personal Health Record Module allowing patients to upload, archive, and retrieve personal health data (e.g. fitness tracker data, heart rate monitor data, blood pressure recordings, etc.) and record vital signs, symptoms, treatments, and medical history.
Home-Based Cardiac Rehab + mHealth (HOM+)	mHealth	Participants will be provided paper copies of educational content at the time of event/discharge. In addition, these participants will be provided access to the same mHealth platform as the CON+ group. Participants in this group will be encouraged to exercise three days per week while also completing the additional questionnaires and educational content provided by the mHealth platform in accordance with the CR program. Participation will be tracked using web/internet analytics.

Primary Outcome Measures

Name	Time	Method
Number of participants who are re-hospitalized during the trial	1 Year	We will look at the number of patients who are hospitalized for any reason during the follow-up period
Functional Capacity	3 Months	VO2 peak

Secondary Outcome Measures

Name	Time	Method
Fasting Blood Glucose	3 Months	All fasting blood chemistry measures will be conducted by standard clinical protocols in the Mayo Clinic laboratories. These measures will be conducted at the time of enrollment in the research program and during each of the two follow-up study visits.
Fasting Hemoglobin	3 Months	All fasting blood chemistry measures will be conducted by standard clinical protocols in the Mayo Clinic laboratories. These measures will be conducted at the time of enrollment in the research program and during each of the two follow-up study visits.
Fasting Hemoglobin A1C	3 Months	All fasting blood chemistry measures will be conducted by standard clinical protocols in the Mayo Clinic laboratories. These measures will be conducted at the time of enrollment in the research program and during each of the two follow-up study visits.
Fasting Basic Lipid Panel	3 Months	All fasting blood chemistry measures will be conducted by standard clinical protocols in the Mayo Clinic laboratories. These measures will be conducted at the time of enrollment in the research program and during each of the two follow-up study visits.
Self-Reported Quality of Life	3 Months	Assessed using Darmouth 9-item short-form health survey
6 Minute Walk Test	3 Months	exercise capacity
Self-Reported Physical Activity	3 Months	assessed via DASI questionnaire
Self-Reported Dietary Patterns	3 Months	obtained using a standard food frequency questionnaire
Change in Body Weight	3 Months	body weight will be measured from pre to post intervention to see if weight decreases

Trial Locations

Locations (2)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States